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Volume 30, Issue 2
Reducing regulatory roadblocks requires more than the stroke of a pen.
Professionals involved in the development and manufacture of new drugs understand that drug development is--by design--a slow, deliberate, detailed, scientific, and technical effort. Getting a drug to market quickly is crucial to meet business objectives and provide needed patient treatments. The goal: accelerate the delivery of safe, efficacious, and cost-effective drugs to patients and to keep a steady supply of safe, efficacious, and cost-effective drugs on the market.
While some in the pharma industry complain the drug development and manufacturing process is overregulated, others seek more direction and guidance from regulatory authorities. In recent years, FDA has been promoting a “carrot” approach to compliance oversight, encouraging drug manufacturers to implement quality measures and, in effect, self-regulate their operations. Unfortunately, due to drug shortages and ongoing quality problems, the “stick” is still needed, in the form of regulations, guidance documents, and inspections, particularly offshore.
The Trump administration lost no time in pushing forward on its campaign promises including the reduction of regulations perceived to be roadblocks to innovation. Executive action, however, may reduce both regulations and regulatory explanations; impact the implementation of the 21st Century Cures Act, the Prescription Drug User Fee Act (PDUFA), and the Generic Drug User Fee Act (GDUFA); and hinder FDA’s ability to approve new and generic drugs.
A Jan. 30, 2017 executive order, “Reducing Regulation and Controlling Regulatory Costs,” set a regulatory cap for fiscal year 2017 and stated that for every proposed new regulation, at least two existing regulations should be identified for repeal. Based on language in the order, both regulations and guidance documents issued by FDA would be included in the “one in-two out” policy. Positioned as an effort to help small businesses, President Donald Trump described the order as “the largest ever cut by far in terms of regulation” in the signing ceremony. He noted that regulation cuts for large business would “be different” but did not specify the differences.
A freeze on the hiring of federal employees was put in place with a Jan. 22, 2017 memorandum. As of this writing, it was unclear if hundreds of vacant positions at FDA would be deemed necessary for public safety and, therefore, exempt from the freeze.
Regulations are developed for many reasons, most notably to implement enacted legislation. Eliminating mandated regulations could require changes or repeals of existing laws, a lengthy process in any political environment. Guidance documents, which explain FDA’s current thinking on regulations, do not have the force of law, but are used by pharma companies for guidance in complying with regulations and are frequently cited by FDA in warning letters to facilities that do not comply.
The process of writing federal regulations and guidance documents requires input and detailed consideration from knowledgeable professionals. FDA consults pharma industry experts when developing regulations and guidance documents, publishing drafts in the Federal Register and soliciting public comment.
The agency planned an ambitious guidance agenda for 2017; 26 guidance documents were slated for revision and 81 new guidance documents proposed. The implementation of the Cures Act and pending reauthorizations of PDUFA and GDUFA should generate the need for even more regulations.
A “one in-two out” strategy could result in the elimination of vital regulations and guidance documents that prescribe practices to ensure the quality of manufactured drugs for the US population here and abroad. The executive order, designed to fulfill a campaign promise, is shortsighted. At a minimum, it creates confusion and uncertainty for a complex drug development and manufacturing system. If followed to the letter, it could create the safety threats, drug shortages, and fraudulent products FDA was established to prevent.
Vol. 30, No. 2
When referring to this article, please cite it as R. Peters, " Regulatory Reform Is Not That Simple," BioPharm Internationa 30 (2) 2017.